LIFECODES® B-Screen® BCSG

GUDID 10888234500063

LIFECODES B-Screen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class II antigens.

IMMUCOR GTI DIAGNOSTICS, INC.

HLA class II antibody screening IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 10888234500063
• NIH Device Record Key: b39d5174-bb02-49ef-9a30-c8c711677d22
• Commercial Distribution Discontinuation: 2019-12-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LIFECODES® B-Screen®
• Version Model Number: BCSG
• Catalog Number: BCSG
• Company DUNS: 606034197
• Company Name: IMMUCOR GTI DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234500063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK990043

FDA Product Code

• KSZ: System, Test, Automated Blood Grouping And Antibody

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-16
• Device Publish Date: 2016-07-08

Devices Manufactured by IMMUCOR GTI DIAGNOSTICS, INC.

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• 10888234500841 - LIFECODES LifeScreen XP: 2023-07-19 LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class I
• 10888234400332 - LIFECODES LSA Class I: 2022-04-14 LIFECODES LSA Class I is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient mat
• 10888234400349 - LIFECODES LSA Class II: 2022-04-14 LIFECODES LSA Class II is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient ma
• 10888234500810 - LIFECODES MATCH IT! Antibody Software v1.4: 2022-02-28
• 10888234500803 - LIFECODES MATCH IT!™ DNA Software v1.3: 2020-03-05
• 10888234500063 - LIFECODES® B-Screen®: 2019-12-16LIFECODES B-Screen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class II antigens.
• 10888234500063 - LIFECODES® B-Screen®: 2019-12-16 LIFECODES B-Screen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodie
• 10888234500094 - LIFECODES® QuikScreen®: 2019-12-16 LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibod